EP4537831A3 - Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien - Google Patents

Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien Download PDF

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Publication number
EP4537831A3
EP4537831A3 EP24220082.2A EP24220082A EP4537831A3 EP 4537831 A3 EP4537831 A3 EP 4537831A3 EP 24220082 A EP24220082 A EP 24220082A EP 4537831 A3 EP4537831 A3 EP 4537831A3
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EP
European Patent Office
Prior art keywords
prophylaxis
vitamin
therapy
calcium
treatment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24220082.2A
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English (en)
French (fr)
Other versions
EP4537831A2 (de
Inventor
Christoph Karl
Rüdiger THIEROLF
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Individual
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Individual
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Publication date
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Publication of EP4537831A2 publication Critical patent/EP4537831A2/de
Publication of EP4537831A3 publication Critical patent/EP4537831A3/de
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Die vorliegende Erfindung beinhaltet pharmazeutische Zusammensetzungen, umfassend Anti-RANKL-Antikörper, Kalzium und Vitamin D, die zur Behandlung und/oder Prophylaxe von Erkrankungen des Knochenstoffwechsels und von therapiebedingten Nebenwirkungen wie Hypokalzämien verursacht durch die Wirkung der Anti-RANKL-Antikörper, geeignet sind.
EP24220082.2A 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien Pending EP4537831A3 (de)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102016006557 2016-05-20
EP24208093.5A EP4501330A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
PCT/EP2017/062087 WO2017198811A1 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
EP17728455.1A EP3458093A1 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
EP24208093.5A Division-Into EP4501330A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
EP24208093.5A Division EP4501330A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
EP17728455.1A Division EP3458093A1 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien

Publications (2)

Publication Number Publication Date
EP4537831A2 EP4537831A2 (de) 2025-04-16
EP4537831A3 true EP4537831A3 (de) 2025-06-04

Family

ID=59021456

Family Applications (3)

Application Number Title Priority Date Filing Date
EP24208093.5A Pending EP4501330A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
EP24220082.2A Pending EP4537831A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien
EP17728455.1A Ceased EP3458093A1 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP24208093.5A Pending EP4501330A3 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP17728455.1A Ceased EP3458093A1 (de) 2016-05-20 2017-05-19 Pharmazeutische zusammensetzungen mit anti-rankl-antikörpern, kalzium und vitamin d, geeignet zur behandlung und/oder prophylaxe von erkrankungen des knochenstoffwechsels und von therapiebedingten nebenwirkungen wie hypokalzämien

Country Status (5)

Country Link
US (2) US20190290756A1 (de)
EP (3) EP4501330A3 (de)
JP (3) JP2019516799A (de)
DE (3) DE202017007720U1 (de)
WO (1) WO2017198811A1 (de)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3634484A4 (de) * 2017-06-05 2022-01-12 The Council of the Queensland Institute of Medical Research Eine kombination von oder ein bispezifisches bindungsmolekül an einen immunkontrollmolekülantagonisten und einen rank-l (nf-kb-ligand)-antagonisten zur krebstherapie oder -prophylaxe und verwendungen dafür

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
US5223409A (en) 1988-09-02 1993-06-29 Protein Engineering Corp. Directed evolution of novel binding proteins
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
IL162181A (en) 1988-12-28 2006-04-10 Pdl Biopharma Inc A method of producing humanized immunoglubulin, and polynucleotides encoding the same
US7067279B1 (en) * 2002-08-23 2006-06-27 Immunex Corporation Cell culture performance with betaine
CR20170085A (es) * 2014-08-07 2017-04-25 Opko Ireland Global Holdings Ltd Terapia adjuntiva con 25-hidroxi vitamina d

Non-Patent Citations (4)

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Title
CUMMINGS STEVEN R ET AL: "Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis", NEW ENGLAND JOURNAL OF MEDICINE, vol. 361, no. 8, August 2009 (2009-08-01), pages 756 - 765, XP002772703, ISSN: 0028-4793 *
EGO SEEMAN ET AL: "Microarchitectural deterioration of cortical and trabecular bone: Differing effects of denosumab and alendronate", JOURNAL OF BONE AND MINERAL RESEARCH, vol. 25, no. 8, 10 March 2010 (2010-03-10), US, pages 1886 - 1894, XP055395196, ISSN: 0884-0431, DOI: 10.1002/jbmr.81 *
POLYZOIS MAKRAS ET AL: "Parathyroid hormone changes following denosumab treatment in postmenopausal osteoporosis", CLINICAL ENDOCRINOLOGY., vol. 79, no. 4, 1 October 2013 (2013-10-01), GB, pages 499 - 503, XP055395128, ISSN: 0300-0664, DOI: 10.1111/cen.12188 *
SUGIMOTO T ET AL: "Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT)", OSTEOPOROSIS INTERNATIONAL, SPRINGER, GB, vol. 26, no. 2, 18 November 2014 (2014-11-18), pages 765 - 774, XP035438564, ISSN: 0937-941X, [retrieved on 20141118], DOI: 10.1007/S00198-014-2964-2 *

Also Published As

Publication number Publication date
EP3458093A1 (de) 2019-03-27
JP2023055905A (ja) 2023-04-18
EP4501330A3 (de) 2025-05-07
EP4501330A2 (de) 2025-02-05
JP2019516799A (ja) 2019-06-20
EP4537831A2 (de) 2025-04-16
DE202017007721U1 (de) 2025-02-11
DE102017110958A1 (de) 2017-11-23
WO2017198811A1 (de) 2017-11-23
DE202017007720U1 (de) 2025-02-11
US20190290756A1 (en) 2019-09-26
JP2025081442A (ja) 2025-05-27
US20230218754A1 (en) 2023-07-13

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